Deaths Halt Part of Large Diabetes Trial

Increased mortality seen in patients receiving aggressive drug therapy to cut blood sugar levels

By Steven Reinberg
HealthDay Reporter

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WEDNESDAY, Feb. 6 (HealthDay News) -- A large North American trial designed to aggressively lower the blood sugar of type 2 diabetics at risk of heart disease has been halted because of an unexpected number of deaths among those receiving the drug therapy.

Federal health officials announced Wednesday that 257 people who received the intensive therapy had died, compared with 203 in patients in a standard treatment group. But they could not pinpoint the reason for the heightened risk, and they appeared to rule out any of the diabetes drugs that were used.

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A segment of the trial, called the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, was stopped 18 months early because of the findings.

"After thoroughly reviewing the data collected to date, ACCORD investigators found that among these adults with type 2 diabetes who are at especially high risk of cardiovascular disease, a medical treatment strategy to intensively lower their blood sugar levels below the current guidelines increased the risk of death compared to standard blood sugar lowering treatment." Dr. Elizabeth G. Nabel, director of the U.S. National Heart, Lung, and Blood Institute (NHLBI), said during a teleconference.

The ACCORD trial, sponsored by the NHLBI, began in 2001 at 77 sites in the United States and Canada with the enrollment of 10,251 patients with type 2 diabetes who were at high risk for heart attack or stroke because they had at least two risk factors, including high blood pressure, high cholesterol or obesity. Those in the trial received either medications to aggressively lower their blood sugar below recommended levels, or standard treatment to control their disease.

Among the 257 deaths in the aggressive therapy group, 50 percent were due to heart attacks or other cardiovascular causes, said Dr. William Friedewald, a clinical professor of public health and medicine at Columbia University and the chairman of the ACCORD Steering Committee.

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